Fluoride Administered and Retained After Topical Fluoride Varnish

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-12-31

Brief Summary

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The specific aim of the study is to determine the excess urinary fluoride and its time course after administration of an application of Premier Enamel Pro Varnish to the teeth of 12-15 month old infants. From these data the investigators can estimate the bioavailable (more precisely the equivalent) dose of sodium fluoride and the peak serum fluoride concentration that will allow an estimate of the margin of safety of the procedure.

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Detailed Description

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Fluoride varnish painted on the teeth is the standard method dentists use to prevent tooth decay (cavities) in preschool children in the United States. Fluoride varnish is not FDA approved specifically for prevention of cavities, but dentists may legally use it for this purpose. We want to study how much fluoride appears in the urine after the painting procedure to improve our knowledge of how the varnish works and its safety. The fluoride varnish is being used for research purposes for this study by permission of FDA (IND #110869).

Premier Dental Product Company's Enamel Pro Varnish will be used. Up to six children aged 12-15 months will be enrolled in this study. We measured urinary fluoride for 5 hours after application of fluoride varnish to teeth. Baseline levels were measured on a separate day.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Fluoride varnish

Topical fluoride

Group Type OTHER

Fluoride varnish

Intervention Type DEVICE

Topical application of fluoride varnish on present teeth

Interventions

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Fluoride varnish

Topical application of fluoride varnish on present teeth

Intervention Type DEVICE

Other Intervention Names

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Premier Enamel Pro

Eligibility Criteria

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Inclusion Criteria

* consent obtained from parent or legal guardian of participant
* children aged 12 - 15 months
* at least 1 erupted tooth
* in general good health

Exclusion Criteria

* known allergy to any drug, latex, nuts, or resin components or components of toothpaste/dental prophylaxis product
* participant has stomatitis or other oral conditions that preclude applying fluoride varnish comfortably

Minimum Eligible Age

12 Months

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes